CTRI Number |
CTRI/2018/02/012105 [Registered on: 23/02/2018] Trial Registered Prospectively |
Last Modified On: |
12/02/2018 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Yoga & Naturopathy |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Role of Yoga on Obstructive Sleep Apnea (OSA) |
Scientific Title of Study
|
Effect of yoga on health-related status and cardiovascular risk factors among obstructive sleep apnoea patients: A Multi-Centric Randomized Controlled Trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Gautam Sharma |
Designation |
Professor, Cardiology and Professor In-charge, Center of Integrative Medicine and Research (CIMR) |
Affiliation |
Centre of Integrative Medicine and Research (CIMR) |
Address |
Centre of Integrative Medicine and Research (CIMR)
Convergence Block,
All India Institute of Medical Sciences (AIIMS)
New Delhi
South DELHI 110029 India |
Phone |
|
Fax |
|
Email |
drsharmagautam@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Gautam Sharma |
Designation |
Professor, Cardiology and Professor In-charge, Center of Integrative Medicine and Research (CIMR) |
Affiliation |
Centre of Integrative Medicine and Research (CIMR) |
Address |
Centre of Integrative Medicine and Research (CIMR)
Convergence Block,
All India Institute of Medical Sciences (AIIMS)
New Delhi
South DELHI 110029 India |
Phone |
|
Fax |
|
Email |
drsharmagautam@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Gautam Sharma |
Designation |
Professor, Cardiology and Professor In-charge, Center of Integrative Medicine and Research (CIMR) |
Affiliation |
Centre of Integrative Medicine and Research (CIMR) |
Address |
Centre of Integrative Medicine and Research (CIMR)
Convergence Block,
All India Institute of Medical Sciences (AIIMS)
New Delhi
South DELHI 110029 India |
Phone |
|
Fax |
|
Email |
drsharmagautam@gmail.com |
|
Source of Monetary or Material Support
|
Centre of Integrative Medicine and Research (CIMR)
Convergence Block,
All India Institute of Medical Sciences (AIIMS)
New Delhi |
|
Primary Sponsor
|
Name |
Ministry of AYUSH |
Address |
Centre of Integrative Medicine and Research (CIMR)
Convergence Block,
All India Institute of Medical Sciences (AIIMS)
New Delhi |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
GAUTAM SHARMA |
All India Institute of Medical Sciences (AIIMS) |
Room number 7004 and 7001
Centre of Integrative Medicine and Research (CIMR)
Convergence Block,
All India Institute of Medical Sciences (AIIMS)
New Delhi South DELHI |
01126549326
drsharmagautam@gmail.com |
BISHAV MOHAN |
DAYANAND MEDICAL COLLEGE AND HOSPITAL |
DAYANAND MEDICAL COLLEGE AND HOSPITAL
Tagore Nagar, Civil Lines, Ludhiana, Punjab 141001 Ludhiana PUNJAB |
9876741158
bishav_68@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
AIIMS IEC |
Submittted/Under Review |
DMCH IEC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
OBSTRUCTIVE SLEEP APNEA, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Control Group |
The patients in the control group will continue to receive the standard medical treatment along with advice on life style modification and dietary changes. Interested candidates will be taught yoga after the completion of the study. |
Intervention |
Yoga with standard of care group |
The intervention group will be taught yoga practices by institutionally trained yoga therapist (as per the protocol enclosed) at CIMR, AIIMS and Dayananda Medical College and Hospital, Ludhiana over a period of six months. During the study duration, the subjects will be invited to CIMR and Dayananda Medical College and Hospital, Ludhiana for the contact classes. There will be 8 continuous supervised sessions of 45 minutes each in the first two weeks and after which during the non-contact period the patients are advised to practice the same at home for 45 minutes each day, at least 5 days a week for next 6 months following randomization. Each session will have a pre-planned curriculum that will be progressively more challenging and which will facilitate adherence and secure repeatability of the intervention.
A log book and picture based booket which will include yoga asanas that will be given to all recruited participants to follow their practice at home including duration and time of practice. Further, biweekly calls and video conferencing will be arranged to ensure their practice at home.
A formal training programme for yoga therapists will be developed and delivered by CIMR. Retreat training will be offered in a similar manner by CIMR in every 6 months to ensure same practice in both the centres. CIMR will routinely monitor the performance of the yoga therapists, so as to improve the performance of the yoga therapists thereby improving the quality of delivery of the Intervention package.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. Patients of all genders and age between 18-70 years.
2. Patients from Delhi NCR for study settings in Delhi.
3. Medical history which is compatible with OSA and AHI more than 15 per hour.
4. Availability of time to include physical activity in their daily routine and to come for the contact classes and investigations as per the protocol.
5. Not been engaged in regular yoga practice or any other alternative medicine for the same desired effect.
|
|
ExclusionCriteria |
Details |
1. Patient’s refusal for Polysomnography.
2. Patients on CPAP.
3. Patients with a well-documented chronic history of congestive heart failure, chronic renal failure or chronic liver failure.
4. Patients having very severe hypoxemia (oxygen saturation <80% for >10% of recording time).
5. Pregnancy
6. Morbid obesity, Hypothyroidism
7. Patients underwent any metabolic surgery
8. Recent trauma to upper respiratory tract
9. Patients on systemic corticosteroid treatment
10. Inability to perform yoga exercises due to orthopaedic or musculoskeletal problems.
11. Patients currently participating in any other clinical trials in the same hospital or any other sites.
|
|
Method of Generating Random Sequence
|
Stratified randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1. Apnoea hypopnea index
2. Oxygen desaturation index (ODI)
3. Heart Rate Variability (HRV) |
Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
Stress and Inflammatory biomarkers |
Baseline,at 3 months, at 6 months, and at 12 months from baseline |
Neuropsychological Evaluation Screening Tool (NEST) and Hindi Mental Status Examination (HMSE) |
Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline |
Wechsler Memory Scale- III (WMS III) Indian Edition |
Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline |
The Pittsburgh Sleep Quality Index (PSQI) |
Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline |
Hamilton’s Depression Questionnaire (HAM-D) |
Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline |
The Hamilton Anxiety Rating Scale (HAM-A) |
Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline |
WHO QoL BREF questionnaire |
Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline |
General metabolic parameters |
Baseline, at 2 weeks,at 3 months, at 6 months, and at 12 months from baseline |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
02/04/2018 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NONE AS OF NOW |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The current study will be a multi-centric, single blinded, parallel group, randomized control trial with four assessment point i.e. Baseline, after 2 weeks, 3 months, 6 months and 12 months. The study will be conducted at two centers i.e. the Dayananda Medical College and Hospital, Ludhiana and Center for Integrative Medicine and Research (CIMR), AIIMS, New Delhi. The participants will be screened and all consenting participants will be recruited from outpatient services of neurology and pulmonary medicine department and from sleep study lab of Dayananda Medical College and Hospital, Ludhiana, after which they will be randomly divided into two groups with an allocation ratio of 1:1. All patients will be assessed for primary and secondary outcomes which include general metabolic measures and inflammatory biomarkers along with neuropsychological measures such as depression, anxiety, memory and QoL at baseline followed by assessments at 2 weeks, 3 months, 6 months and 12 months from baseline. The intervention group will receive the intervention (as defined below) whereas the control will continue to receive standard care at each of the center. |